Tornier Flex Cemented Humeral Stem - Uncoated shoulder humeral stem prosthesis

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Stryker Australia Pty Ltd

class:

Class III

manufactured_by:

Tornier SAS 161 rue Lavoisier, Montbonnot, Saint Martin, 38330 France

therapeutic_area:

34197 - Uncoated shoulder humeral stem prosthesis

therapeutic_indication:

Anatomic configuration: Attached to a humeral head component, it is intended for shoulder hemiarthroplasty (if the natural glenoid provides a sufficient bearing surface), or as part of a total shoulder replacement (in conjunction with a glenoid component). Reverse configuration: Intended for replacement of the shoulder joint in conjunction with the reversed adapter (composed of a reversed tray and insert) and glenoid implants. The stem is uncoated titanium alloy and is for cemented use only. A component of the Tornier Flex Shoulder System intended for use as a replacement of shoulder joints in primary anatomic or in primary reverse, and a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The Tornier Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.

authorization_status:

A

authorization_date:

2013-12-20